FDA — authorised 20 June 2017
- Application: NDA022063
- Marketing authorisation holder: TAKEDA PHARMS USA
- Local brand name: MYDAYIS
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 MYDAYIS in United States
FDA authorised MYDAYIS on 20 June 2017
Marketing authorisations
FDA
- Status: approved
Other Other approved in United States
Frequently asked questions
Is MYDAYIS approved in United States?
Yes. FDA authorised it on 20 June 2017; FDA has authorised it.
Who is the marketing authorisation holder for MYDAYIS in United States?
TAKEDA PHARMS USA holds the US marketing authorisation.